Details for New Drug Application (NDA): 210332

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NDA 210332 describes DEXTROSE 5% AND LACTATED RINGER'S, which is a drug marketed by Fresenius Kabi Usa and Icu Medical Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the DEXTROSE 5% AND LACTATED RINGER'S profile page.

The generic ingredient in DEXTROSE 5% AND LACTATED RINGER'S is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.

Tradename:	DEXTROSE 5% AND LACTATED RINGER'S
Applicant:	Fresenius Kabi Usa
Ingredient:	calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate
Patents:	0

Mechanism of Action	Osmotic Activity Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 5% AND LACTATED RINGER'S	calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate	INJECTABLE;INJECTION	210332	ANDA	Fresenius Kabi USA, LLC	65219-241	65219-241-10	10 BAG in 1 CASE (65219-241-10) / 1000 mL in 1 BAG (65219-241-00)
DEXTROSE 5% AND LACTATED RINGER'S	calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate	INJECTABLE;INJECTION	210332	ANDA	Fresenius Kabi USA, LLC	65219-243	65219-243-50	20 BAG in 1 CASE (65219-243-50) / 500 mL in 1 BAG (65219-243-01)

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML
Approval Date:	Mar 28, 2022	TE:		RLD:	No

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